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Showing 3471–3480 of 69883 articles for “Art. I-1°-a ter”
…the provisions of Article R. 5121-168, any company or organisation exploiting an authorised or registered medicinal product or product, in accordance with the procedure laid down in 1° of Articles R.…
If the coordination group agrees, at the end of the single assessment procedure for periodic safety update reports provided for in Article 107g(1) of Directive 2001/83/EC of the European Parliament an…
…uct or product. The frequency of transmission of the report referred to in the first paragraph is determined in the marketing authorisation. The date of transmission in accordance with this frequency…
The marketing authorisation holder may, by written reasoned request, refer the matter to the Committee for Medicinal Products for Human Use referred to in Article 56 of Regulation (EC) No 726/2004 of…
…pital and magistral preparations that they produce, of which they are aware, without delay and no later than fifteen days following receipt of the information ; 2° Any non-serious adverse reaction sus…
The declarations and the periodic safety update report referred to in Articles R. 5121-161, R. 5121-168 and R. 5121-170 are drawn up in accordance with the procedures and standard form laid down by th…
Any company or organisation exploiting a medicinal product or a product mentioned in Article R. 5121-150 implements procedures to obtain accurate and verifiable information for the scientific evaluati…
The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a r…
The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité…
The Minister responsible for health shall determine: 1° By order issued on a proposal from the Agence de la biomédecine, the recommendations of good practice relating to the methods of access, care fo…
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